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GW823093C For The Treatment Of Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00370942
Recruitment Status : Terminated (Safety issue)
First Posted : September 1, 2006
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study was designed to find dose response and as extension in treatment of GW823093C.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: GW823093C A Drug: GW823093C B Drug: GW823093C C Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: GW823093 Japan Phase IIa Mono
Study Start Date : April 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: GW823093C A
A=45 mg
Drug: GW823093C A
A=45 mg

Placebo Comparator: GW823093C B
B=30 mg
Drug: GW823093C B
B=30 mg

Placebo Comparator: GW823093C C
C=15 mg
Drug: GW823093C C
C=25 mg




Primary Outcome Measures :
  1. Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Long term safety variables [ Time Frame: 64 weeks ]


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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Type 2 diabetes mellitus.
  • Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))

Exclusion criteria:

  • Patients who have metabolic disease judged by investigator as a clinically significance
  • Serious cardiovascular disease or serious hepatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370942


Locations
Japan
GSK Investigational Site
Hokkaido, Japan, 051-0005
GSK Investigational Site
Miyagi, Japan, 985-0852
GSK Investigational Site
Tokyo, Japan, 130-0004
GSK Investigational Site
Tokyo, Japan, 160-0017
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00370942     History of Changes
Other Study ID Numbers: DPB106652
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017

Keywords provided by GlaxoSmithKline:
GW823093C
diabetes
type 2 diabetes mellitus
DPP-IV inhibitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases